Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in levels of intermediate biomarkers in prostate tissue (Ki-67, Bcl2, cyclin D, KiP1/P27, VEGF, and CD31) during treatment with defined green tea catechin extract or placebo during the period between biopsy and prostatectomy
研究概览
简要总结
This randomized pilot phase II trial studies the side effects and how well defined green tea catechin extract works in treating patients with localized prostate cancer undergoing surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the growth of certain cancers.
详细描述
OBJECTIVES:
I. To evaluate the short-term effects of daily Polyphenon E (defined green tea catechin extract) administration (800 mg epigallocatechin-3-gallate [EGCG] once daily [QD]) during the interval between prostate biopsy and radical prostatectomy (approximately 6 weeks) in men with localized prostate cancer.
II. Compare the change in levels of intermediate biomarkers (Ki-67, B-cell lymphoma 2 [Bcl2], cyclin D, KiP1/P27, vascular endothelial growth factor [VEGF], and cluster of differentiation [CD]31) in biopsy (pre-treatment) and prostatectomy (post-treatment) specimens collected from subjects treated with Polyphenon E or placebo during the period between biopsy and prostatectomy.
III. Compare the change in pre- and post-treatment serum prostate-specific antigen (PSA) level in subjects treated with Polyphenon E or placebo during the period between biopsy and prostatectomy.
IV. Evaluate bioavailability of catechins from Polyphenon E (plasma and tissue catechin levels, catechin metabolites in urine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate biopsy positive for cancer; clinically localized T1 and T2 stage disease expected, with biopsy specimen available for baseline biomarker measurements
- •Scheduled for a radical prostatectomy
- •Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
- •Willing and able to take oral medications
- •Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea constituents for the duration of the study
排除标准
- •Prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
- •Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization
- •Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- •Serum creatinine >= 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) >= ULN
- •Aspartate aminotransferase (AST) >= ULN
- •Alkaline phosphatase (ALP) >= ULN
- •Albumin (ALB) =< lower limit of normal (LLN)
- •Total bilirubin >= ULN
- •Known malignancy at any site within the last five years; with the exception of basal cell carcinoma (BCC)
- •Participation in a research trial within the past three months
- •Any condition that would interfere with the ability to give informed consent or comply with the study protocol
- •Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
- •Concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
结局指标
主要结局
Change in levels of intermediate biomarkers in prostate tissue (Ki-67, Bcl2, cyclin D, KiP1/P27, VEGF, and CD31) during treatment with defined green tea catechin extract or placebo during the period between biopsy and prostatectomy
时间窗: Baseline and at or after 6 weeks of treatment
次要结局
- Changes in the levels of free (f) PSA(After 0, 4, and 6 weeks)
- Catechin levels(At baseline, 4 weeks after supplementation, and at time of surgery)
- Number of pts with adverse events as a measure of safety and tolerability(At baseline and every 4 weeks)
- Changes in the levels of total (t) PSA(After 0, 4, and 6 weeks)